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The Role of Coding & Marking in the Medical Devices Sector

By Volker Watzke

May 22, 2018

Medical Devices

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Author

Volker Watzke is Domino's European Medical Devices Sector Manager

Summary

Based on manufacturer prices, the European medical technology market is worth €110 billion and is estimated to make up 28% of the world market, making it the second largest in this sector after the USA. Market research reveals that small and medium-sized companies (SME's) make up almost 95% of the EU industry and that the majority of them employ less than 50 people-per-company.

The technology to assign, apply and verify identification codes to a wide range of products is an invaluable asset. Benefits are varied and apply to numerous industries such as the medical sector where Unique Device Identification (UDI) is the accepted method for identifying and tracking medical devices throughout their life cycles, from production through to distribution and finally to consumer use.

The implementation of product codes onto medical devices results in more efficient recall procedures, the reduction of medical errors, increased inventory visibility and supply chain security. The unique codes applied to each item during the manufacturing stages will provide the supply chain management system with critical information, such as what the product is, where and when it was produced. In the event a recall is necessary due to a product being faulty, the code is crucial to unlocking the so-called ‘chain of custody', allowing the item in question to be traced back to its origin.

As is the case with other industries, counterfeit products can harm a medical brand in many ways, from affecting business revenues to destroying consumers' faith in the brand through poor-quality imitations. More crucially, fake products can endanger consumers' health. Illicit trade can be even more detrimental, as it goes beyond simple counterfeiting to encompass equally damaging activities such as product diversion, where entirely genuine products are deflected from intended channels into ones unauthorised by the manufacturer. With this in mind, item-level identification proves to be useful in helping to distinguish legitimate products from the false ones, while also assisting governments to stem the erosion of revenues and jobs caused by illicit trade.

With the May 2020 deadline now set in place to comply with the mandatory requirements of the EU Medical Device Regulation, manufacturers have been given a timeframe to ensure they have all the affected areas of their business covered, including product identification. To see more on the EU regulations, download our white paper.